This invention generally relates to a system for holding flexible elongated articles in a coiled condition and particularly for sterile elongated articles such as dilatation catheters and guidewires for percutaneous transluminal coronary angioplasty (PTCA).
In PTCA procedures, a guiding catheter having a preshaped distal tip is percutaneously introduced into the cardiovascular system of a patient and advanced therein uptil the preshaped distal tip thereof is disposed within the aorta adjacent the ostium of the desired coronary artery. The guiding catheter is twisted or torqued from the proximal end to turn the distal tip of the guiding catheter so that it can be guided into the coronary ostium. A dilatation catheter having a balloon on the distal end thereof is introduced into and advanced through the guiding catheter to the distal tip thereof and then out of the distal tip of the guiding catheter until the balloon on the distal extremity of the dilatation catheter is properly positioned across the lesion. Once properly positioned, the flexible, relatively inelastic balloon tis inflated to a predetermined size with radiopaque liquid at relatively high pressures (e.g., 4-12 atmospheres) to dilate the stenosed region of the diseased artery. The balloon is then deflated so that the dilatation catheter can be removed from the dilated stenosis and blood flow can then be resumed therethrough. With over-the-wire and rapid exchange type dilatation catheters, they are advanced out of the guiding catheter over a previously positioned guidewire to the desired location within the patient's coronary anatomy. With fixed wire catheters the guiding member is fixed within the catheter so both are advanced together out the distal end of the guiding catheter to the desired location within the coronary arteries of the patient.
When a dilatation catheter or a guidewire is being manipulated during an angioplasty procedure, care must be exercised to ensure that the sterility of the catheter or the guidewire is not compromised by accidental contact with a non-sterile surface such as the floor or surrounding non-sterilized equipment. When not being used during the procedure, an unpackaged intravascular device, which can be over three feet long, usually must be placed in a sterile environment until it is used in the angioplasty procedure. This typically involves laying the catheter or the guidewire in an uncoiled condition over the draped surgical site on the patient. However, while the draped surgical site is sterile, it is not uncommon for the intravascular device to come into contact with a non-sterile surface due to all of the activity at the surgical site. Such contact with a non-sterile surface requires the contaminated intravascular device to be discarded and another sterilized intravascular device to be prepared for the angioplasty procedure. This replacement is expensive and inconvenient for the physician because a replacement catheter must also be vented to remove entrapped air and a replacement guidewire may need to have its distal extremity shaded.
Examples of instances during the angioplasty procedure in which an elongated dilatation catheter or guidewire can come into contact with a non-sterile surface requiring replacement of the compromised sterile product include when mounting a dilatation catheter onto a guidewire or withdrawing a dilatation catheter over a guidewire. Such intravascular devices also can come into contact with nonsterile surfaces when being stored for later use in a different artery.. The risk of non-sterile contact is particularly high when manipulating an assembled rapid exchange type dilatation catheter and a guidewire.
What has been needed and heretofore unavailable is a system which holds elongated intravascular devices in a relatively compact arrangement, particularly with sterilized devices, in order to minimize accidental contact with non-sterile surfaces. The present invention satisfies this and other needs.